MAUDE Adverse Event Report: CONMED CORPORATION CONMED REFLEX ONE SKIN STAPLER; STAPLER, SURGICAL

Catalog Number 8035

Device Problem Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  malfunction  

Event Description

Skin stapler malfunctioned.Trigger was pulled once and two staples came out.The first one embedded into the skin properly, and the second one went in on one side only.Fda safety report id #: (b)(4).

• Brand Name: CONMED REFLEX ONE SKIN STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 10244956
• MDR Text Key: 198185826
• Report Number: MW5095417
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 00653405036923
• UDI-Public: (01)00653405036923
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: 8035
• Device Lot Number: 201901314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 46